DIABETIC MACULAR EDEMA
Conditions
Keywords
CATARACT EXTRACTION, MACULAR EDEMA, DIABETES, FOCAL LASER, TRIAMCINOLONE
Brief summary
The purpose of this study is to determine if intravitreal triamcinolone acetonide (IVTA) injection at the time of cataract surgery will improve visual acuity and decrease post-operative swelling in diabetic patients requiring cataract extraction as compared to the conventional treatment of laser following cataract surgery. The subjects will be followed for 11 visits over 3 year. Visits will occur at screening,1, 3,6,9,12,18,24,30 and 36 months post surgery.
Detailed description
Protocol Summary: This is a randomized, prospective study comparing diabetic patients with pre-operative macular edema undergoing cataract surgery treated with either 4 mg of intravitreal triamcinolone at the time of cataract surgery or focal laser treatment 1 month following cataract surgery. Disease State: The conventional treatment for clinically significant macular edema is focal laser photocoagulation. In some diabetic patients however, the cataract often impedes fundus visualization for optimal laser treatment. In these patients focal laser treatment is deferred until after cataract surgery. Study aim: The purpose of this study is to determine if intravitreal triamcinolone acetonide (IVTA) injection at the time of cataract surgery will improve visual acuity and decrease post-operative macular edema in diabetic patients with pre-operative macular edema requiring cataract extraction as compared to the conventional treatment of focal laser photocoagulation following cataract surgery. Hypothesis: We propose that by injecting triamcinolone intravitreally at the time of cataract surgery in patients who have pre-operative macular edema, we will not only reduce the risk of exacerbating macular edema but also possibly improve the final visual outcome. Study Procedures: After informed consent is obtained each patient will be placed, based on a randomization scheme, into either the control group receiving the conventional focal laser treatment one month following cataract extraction or into the study group receiving the IVTA injection at the time of surgery.
Interventions
DRUGTriamcinolone acetonide
4mg of intravitreal triamcinolone at time of cataract surgery with option to repeat at one month if no response
PROCEDURElaser
Laser treatment 1 month after cataract surgery with option to repeat once if no improvement.
Sponsors
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* visually significant cataracts * pre-operative visual acuity 20/50 or worse * pre-operative optical coherence tomography (OCT) showing at least 250 microns central foveal thickness.
Exclusion criteria
* macular ischemia * vitreomacular traction * macular hole
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Outcome Measures Will be Quantitative Changes in OCT Central Thickness, Visual Acuity, and Number of Snellen Acuity Lines Gained/Lost. | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Rate of Elevated Intraocular Pressures, Retinal Detachment, Infection, and Vitreous Hemorrhage. | 3 years |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Laser Therapy If randomized to laser therapy at time of cataract surgery, laser therapy will be performed one month after cataract surgery. If macular edema does not respond an additional laser therapy will be performed. If macular edema persists after 2 lasers, then IVTA will be administered as per standard of care.
laser: Laser treatment 1 month after cataract surgery with option to repeat once if no improvement. | 6 |
| Triamcinolone Therapy At time of cataract surgery, will have IVTA injection. If macular edema does not show improvement at 1 month, then can have repeat IVTA injection. If the macular edema is stil not improved after 2nd injection, participant will be considered treatment failure and will be given the option to have laser therapy.
Triamcinolone acetonide: 4mg of intravitreal triamcinolone at time of cataract surgery with option to repeat at one month if no response | 5 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 3 | 2 |
Baseline characteristics
| Characteristic | Laser Therapy | Triamcinolone Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 4 Participants | 9 Participants |
| Region of Enrollment United States | 6 participants | 5 participants | 11 participants |
| Sex: Female, Male Female | 6 Participants | 4 Participants | 10 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 6 | 0 / 5 |
| other Total, other adverse events | 0 / 6 | 1 / 5 |
| serious Total, serious adverse events | 1 / 6 | 0 / 5 |
Outcome results
Primary
Main Outcome Measures Will be Quantitative Changes in OCT Central Thickness, Visual Acuity, and Number of Snellen Acuity Lines Gained/Lost.
Time frame: 3 years
Population: Due to lack of follow up from patients, this outcome was not analyzed; data were not collected
Secondary
Rate of Elevated Intraocular Pressures, Retinal Detachment, Infection, and Vitreous Hemorrhage.
Time frame: 3 years
Population: Data were not collected